Section 345IAC8-3-1. Incorporation by reference; standards

   (a) The board incorporates by reference as a rule of the board the Grade A Pasteurized Milk Ordinance, United States Department of Health and Human Services, Public Health Service, Food and Drug Administration (2013 revision), referred to as the PMO for regulation of the production, transportation, processing, handling, sampling, examination, grading, labeling, and sale of all Grade A milk and milk products in the state. Except where specifically excluded, the board intends to incorporate all parts of the PMO to include all of the administrative procedures and the appendixes. However, the following parts of the PMO are not incorporated by reference as a rule of the board:

(1) Section 16 on penalties.

(2) Section 17 on repeal and date of effect.

(3) Appendix P.

The board intends to incorporate the footnoted language in the PMO regarding cottage cheese that will apply to any person producing Grade A cottage cheese and Grade A dry curd cottage cheese. However, a person may produce cottage cheese and dry curd cottage cheese as a manufacturing grade milk product (not Grade A) by complying with the manufacturing grade milk products requirements under this article. References in the PMO to the regulatory agency shall mean and refer to the board.

  (b) The board will utilize the latest edition of the following documents when interpreting and implementing the provisions of the PMO, this article, and IC 15-18:

(1) The following National Conference on Interstate Milk Shipments model documents:

(A) Procedures Governing the Cooperative State-Public Health Service / Food and Drug Administration Program of the National Conference on Interstate Shipments.

(B) Methods of Making Sanitation Ratings of Milk Shippers.

(C) Evaluation of Milk Laboratories.

(2) The following sets of documents issued by the United States Food and Drug Administration, Milk Safety Branch:

(A) Memoranda of Interpretation (M-a series documents).

(B) Memoranda of Milk Ordinance Equipment Compliance (M-b series documents).

(C) Memoranda of Information (M-I series documents).

  (c) The board adopts by reference the general provisions relating to food standards set forth by the United States Food and Drug Administration in 21 CFR 130.8, 21 CFR 130.9, 21 CFR 130.10, and 21 CFR 130.11, in effect on April 1, 2014.

  (d) The board adopts by reference the definitions and standards of identity for milk and milk products set forth by the United States Food and Drug Administration in 21 CFR 131.3 et seq., titled "Part 131–Milk and Cream", in effect on April 1, 2014. Milk and milk products must conform to these standards.

  (e) The board adopts by reference the definitions and standards of identity for cheeses and related cheese products set forth by the United States Food and Drug Administration in 21 CFR 133.3 et seq., titled "Part 133–Cheeses and Related Cheese Products", in effect on April 1, 2014. Cheese and cheese products must conform to these standards.

  (f) The board adopts by reference the definitions and standards of identity for frozen desserts set forth by the United States Food and Drug Administration in 21 CFR 135.3 et seq., titled "Part 135-Frozen Desserts", in effect on April 1, 2014. Frozen desserts must conform to these standards.

  (g) The board adopts by reference the current good manufacturing practices for manufacturing, packing, or holding human food set forth by the United States Food and Drug Administration in 21 CFR 110 and 21 CFR 113, in effect on April 1, 2014. The criteria and definitions in 21 CFR 110, 21 CFR 113 and this rule shall apply in determining whether a food is adulterated under IC 15-18-1 in that the food has been manufactured under such conditions that it is unfit for human food or the food has been prepared, packed, or held under unsanitary conditions under which the product may:

(1) become contaminated with filth; or

(2) have been made injurious to health.

  (h) The board adopts by reference as a rule of the board the food labeling requirements set forth by the United States Food and Drug Administration in 21 CFR 101, but not including Subpart C, in effect on April 1, 2014.

  (i) The board incorporates by reference into this rule the definitions set forth in IC 15-17-2 and the matters set forth in IC 15-18-1.

  (j) Where the matters incorporated by reference in this section conflict with provisions of this article, IC 15-17-2, or IC 15-18-1, the express provisions of this article and the Indiana Code shall control.

  (k) Incorporated documents are available for public inspection at the board. Copies of incorporated documents and interpreting and implementing documents may be obtained from the Food and Drug Administration, Milk Safety Branch website, the U.S. Government Printing Office website, or by sending a written request to the board. (Indiana State Board of Animal Health; 345 IAC 8-3-1; emergency rule filed Jan 27, 1994, 5:00 p.m.: 17 IR 1223, eff Feb 1, 1994; filed Apr 17, 1998, 9:00 a.m.: 21 IR 3354; errata filed Aug 13, 1998, 1:16 p.m.: 22 IR 126; readopted filed May 2, 2001, 1:45 p.m.: 24 IR 2895; filed Sep 27, 2002, 2:40 p.m.: 26 IR 340; filed Jul 18, 2005, 1:00 p.m.: 28 IR 3564; readopted filed May 9, 2007, 3:16 p.m.: 20070516-IR-345070037RFA; filed Dec 18, 2007, 3:45 p.m.: 20080116-IR-345070296FRA; filed Aug 11, 2008, 3:37 p.m.: 20080910-IR-345080125FRA; errata filed Oct 3, 2008, 3:30 p.m.: 20081022-IR-345080767ACA; filed Dec 10, 2010, 10:42 a.m.: 20110105-IR-345100123FRA; filed Sep 11, 2012, 2:35 p.m.: 20121010-IR-345120107FRA; filed Dec 4, 2014, 1:59 p.m.: 20141224-IR-345140199FRA) NOTE: Transferred from the Indiana State Department of Health (410 IAC 8-14-8.1) to the Indiana State Board of Animal Health (345 IAC 8-3-1) by P.L.138-1996, SECTION 76, effective July 1, 1996.